Cleared Special

K221901 - EleGARD

K221901 is an FDA 510(k) clearance for EleGARD, manufactured by Advancedcpr Solutions, LLC. The device is a Class 1 General Hospital device with product code FOA cleared through the Special 510(k) pathway after a 29-day FDA review.

K221901 · Advancedcpr Solutions, LLC · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2022
Decision
29d
Days
Class 1
Risk

K221901 is an FDA 510(k) clearance for the EleGARD. Classified as Board, Cardiopulmonary (product code FOA), Class I - General Controls.

Submitted by Advancedcpr Solutions, LLC (Edina, US). The FDA issued a Cleared decision on July 29, 2022 after a review of 29 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6080 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K221901

510(k) Number K221901 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 2022
Decision Date July 29, 2022
Days to Decision 29 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 129d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

FOA Device Classification - Class 1, General Controls

Product Code FOA Board, Cardiopulmonary
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6080
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Consultant

ProMedic Consulting, LLC
Paul Dryden

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.